Final Results

NMT Group PLC 23 April 2001 23 April 2001 NMT GROUP PLC PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2000 NMT Group, the manufacturer of retractable devices to prevent needlestick injury, announces its preliminary results for the year ended 31 December 2000. Announced Today (see separate press announcements) * Distribution agreement with Southern Syringe Services, leading UK hospital products distributor, giving NMT national coverage of the UK hospital market * Distribution agreement with Medcore AB in Sweden Highlights for the Period * Loss (pre-exceptional items) of £10.2m (1999: £7.1m) in line with expectations * Successful £24.1m (net) Placing and Open Offer completed in July 2000 * Good progress made towards resolution of manufacturing issues * Volume and quality of 3cc syringe output showing dramatic improvement * 1cc syringe now being manufactured * Strengthening of senior management team * Contract awarded to supply syringes to Premier, largest group purchasing organisation in US * NMT's product offering broadened through IV safety catheter supply agreement with Eastern Medikit of India; further such agreements anticipated * Needlestick Safety and Prevention legislation enacted in the US in November 2000 * Favourable outcome in first phase of patent infringement litigation Commenting on the results, Roy Smith, Chief Executive Officer, said: 'Over the past twelve months, we have made very substantial progress in resolving the manufacturing challenges which faced NMT. 2001 will be a critical year as we make the transformation to high volume manufacture. With the passing of the needlestick legislation in the US at the end of last year and the growing awareness of safety issues in Europe, we remain convinced that there is a significant commercial opportunity for NMT and are confident that we will secure strong growth in future years.' Enquiries: NMT Group PLC Tel: 02380 619612 Roy Smith, Chief Executive Officer Tony Fletcher, Chief Operating Officer Financial Dynamics David Yates/Fiona Noblet Tel: 0207 831 3113 CHAIRMAN'S STATEMENT A year ago I announced the appointment of Roy Smith as our new Chief Executive. At our Annual General Meeting on 11 May, Roy confirmed that he was undertaking a thorough review of the business and that the Group would require funding in the short term. During the fundraising, a business plan was developed which would enable the Group to develop its manufacturing capacity of safety syringes and to provide a broader range of safety products. One year on, I am able to report that we raised £24.1m (net of expenses) from new and existing shareholders in July, which has provided us with the necessary capital to address our manufacturing issues and enable us to build a platform to allow high quality/high speed assembly of 3cc and 1cc syringe products. Since Roy's arrival, we have continued to move from a 'start-up' management team to one that is able to build and manage a fully operational, international manufacturing and marketing organisation. Throughout the latter half of 2000, the Group made excellent progress in resolving the manufacturing challenges and, while further work will be required during this year, I remain confident that the results of these efforts will become evident during 2001. Losses for the year of £13.2m (1999: £7.1m) were realised on turnover of £0.4m (1999: £66,000) and were in line with expectations. These losses included £ 3.0m of exceptional administration expenses, of which £1.7m related to a provision for the impairment to the value of intellectual property rights, as a result of product design changes and the global re-branding programme. The remainder of these expenses relate to restructuring costs. The loss per share of 8.8p compared with a loss of 12.6p in 1999. The balance sheet remained strong with a cash balance of £19.9m at the end of the year. As reported in our Interim Results, Harry Bocker (Finance Director and Deputy Chief Executive), Michael Brander (Corporate Director and Company Secretary) and Garry McGrotty (Commercial Director) resigned from the Board in May. I am pleased to welcome Tony Fletcher who joined the Board in June 2000. In his role as Chief Operating Officer and Finance Director, Tony's wealth of experience in both manufacturing and finance is proving invaluable to the Group. The senior management team has been further strengthened with the appointment of Iain Kennedy as General Manager of the Livingston facility and Steve Czick as President of New Medical Technology Inc., our US Company. These appointments have brought additional management skills and experience that are essential to the fulfilment of NMT's strategy. The calibre of NMT's staff has undoubtedly been reinforced during 2000. Whilst there are the inevitable management changes following the introduction of a new senior management team, we are fortunate in having a dedicated, skilled workforce. We were 166 strong at the close of the year and expect to increase to a headcount in excess of 200 in 2001. Without the support of our dedicated workforce, the Company could not have transformed itself so quickly. The need to avoid needlestick injury is now recognised internationally. The enactment in the US of the Needlestick Safety and Prevention legislation in November 2000 confirms that North America will be NMT's main market and therefore the principal driver of our manufacturing plans. I believe that high quality automatic retraction needle devices will be the future safety products of choice and that NMT syringes are the best available. We have made favourable progress with regard to the two patent infringement lawsuits brought by Medsafe Technologies LLC and Syringe Development Partners LLC against the Group. Summary Judgment in regard to non-infringement of the first patent has been awarded in favour of the Company and New Medical Technology Inc. I continue to believe that the outstanding patent claims can also be successfully defended. Our strategy is to broaden our product portfolio so that we can offer an extensive range of safety syringes and other safety products that utilise our safety needle technology. We will continue to expand our syringe assembly at Livingston, but will also consider contracting out manufacture of other safety devices, where appropriate. We have laid the foundations of a high quality safety needle company, which I believe will be able to participate fully in the rapidly expanding world market. I am confident that the team now in place will deliver our planned business strategy. Roger Gilmour Chairman CHIEF EXECUTIVE'S REVIEW Achievements 'The key achievement during 2000 and early 2001 was the creation of a robust platform to allow a ramp up in manufacturing that, in turn, should deliver good sales growth during the remainder of 2001.' The year 2000 was clearly a watershed for NMT Group PLC. Late in 1999 and early 2000, the Group's major problem was its inability to manufacture a range of 3cc products in high volume at the appropriate quality. I joined the Company as Chief Executive in April 2000 and was shortly joined in June by Tony Fletcher, Chief Operating Officer and Finance Director. Tony and I were most encouraged by NMT's technology and we firmly believed that while the Group was facing severe difficulties, with additional investment it would be possible to significantly improve the performance of the business. Furthermore, the ever-increasing demand in the US for legislation mandating the use of safety needle devices demonstrated that the commercial opportunity for NMT was, and still remains, unquestionable. In June, a thorough review of the business was completed and the required funding was identified to provide the necessary cash to deliver a ramp up in manufacture, to invest in sales and marketing, and to broaden the safety product portfolio. A successful Placing and Open Offer was completed during July and the Company raised £24.1m net of issue costs. Throughout the summer and latter part of 2000, substantial restructuring was undertaken to strengthen the management team across all functions within the Group. One immediate move was the formation of cross-functional project teams, designed to ensure a multi-disciplinary approach to problem solving in all fields, including production, manufacturing engineering, quality and product design. These teams were able to harvest the expertise that existed throughout the Company and to deal with major areas of concern in a structured and disciplined manner. By the close of 2000 nine out of the eleven components in the 3cc syringe had been re-designed in order to increase end-use functionality and to facilitate high volume manufacture. The Group has formed close relationships with its suppliers who have been highly supportive in assisting the Group to meet its objectives. An additional key area of focus has been the strengthening of our sales and marketing organisation to ensure that we can obtain appropriate value for our product offering, optimise the market access opportunity, and confirm that future product launches are in line with customer expectations. Operational review 'To provide a platform to underpin consistent high volume output' To achieve our operational objectives, management time was directed to three key areas: assembly process, product design and people. Assembly process Re-engineering of the assembly process has been essential and substantial effort has been applied to redesigning the component assembly and handling processes. Two of the most fundamental changes made to the 3cc manufacturing equipment related to syringe end cap assembly and spring manufacture. In late 2000, a new end cap bonding process was developed and trials were undertaken with the supplier of NMT's assembly equipment. During February 2001, the existing equipment was successfully modified. Our original assembly equipment configuration included integrated spring coilers, which proved unreliable and erratic. Following detailed analysis, NMT decided to outsource spring manufacture to a supplier with many years experience in this type of industry. There have been numerous other changes to the assembly equipment, which have improved manufacturing efficiencies. Product design During the year, customer feedback indicated that the syringe was not performing to an optimum level and that further design work was necessary. The functionality of the syringe improved considerably in the last months of 2000 following our re-design programme. We are confident that the quality of finished product is now of an appropriately high standard to defend its added value premium. Additionally, we have extended the range of 3cc syringes with various needle sizes on offer to customers. People Iain Kennedy joined the Group as General Manager of the Livingston facility in June 2000 and has proved a great asset, possessing a wealth of experience within highly automated assembly businesses. He is a 'hands on' senior executive who has been instrumental in creating the multi-functional team approach to problem solving. Business unit management has been introduced at Livingston, whereby each automated assembly machine comprises its own engineering and quality support functions. In addition to production personnel, these support staff report directly to each unit manager. The Group has invested heavily in manufacturing engineering resource, which is critical to ensuring the reliability of our production machines. We have also worked far more closely to develop partnerships with suppliers, including manufacturers of assembly equipment, multi-cavity tooling and injection moulding. It was critical that these suppliers should understand our requirements and work with us to devise robust solutions. 'Broadening the product offering' Throughout 2000, the major objective of ensuring that the Sortimat assembly machines were capable of manufacturing the full range of 3cc syringes was largely accomplished. NMT took receipt of a third Sortimat machine in March 2001, which will provide additional manufacturing capacity of 3cc syringes. In August 2000, NMT received delivery of a Mikron assembly machine, which is now fully validated. The Mikron line is specified to produce a full range of 1cc products, a critical complement to the 3cc offering. During 2001, we will consider expanding our manufacturing capacity to include 5cc syringes to serve the European market. We have appraised several manufacturing companies to assess their suitability as suppliers of other NMT patented safety devices. One such company is Eastern Medikit of New Delhi, a leading manufacturer of intravenous (IV) catheters. We have chosen Eastern Medikit to manufacture our IV safety catheter, which was developed in-house and is intended for launch towards the close of 2001. In the short term, the Livingston facility will focus on the assembly of NMT's range of high value syringes. Our strategy will be to outsource the manufacture of additional devices to other companies, which can achieve appropriate cost and quality standards. 'Areas of focus 2001' The primary objective during this coming year will be to take the Group to profitability in 2002. NMT will focus on continuous improvement and an aggressive added-value engineering programme. We will continue to invest in people and their training requirements, important activities that will underpin our demanding growth and cost targets. Research and development The top priority of the research and development group has been to deliver the redesign of the current syringe product range to facilitate high volume manufacture. The current device remains subject to continuous design improvement to reduce unit cost. This will be critical, as the requirement to deliver large volumes at lower cost becomes of increasing importance in the medium-term. In addition to its core portfolio, the Group is developing a broad range of other safe needle devices, which we intend to launch during late-2001 and into 2002. These include intravenous (IV) catheters, butterfly and phlebotomy products (blood draw). The design criteria are that such products should be easy to manufacture, be cost effective and complementary to the syringe offering. During 2000, work was started to develop a series of options to provide a pre-fill safety syringe using NMT's in-house needle retraction technology. NMT is looking externally to facilitate market entry into this growth area, by seeking formal alliances with leading pharmaceutical companies to fund the commercialisation of this technology. The criteria for all new product development, which will be synergistic with the NMT business strategy, are as follows: - High degree of safety - Significant clinical value - Little change to clinical practice - Good margin - Global brand equity - Strong intellectual property Regulatory, quality assurance and intellectual property The NMT quality system remains core to our business. During the year 2000, we were audited by SGS Yardsley International Certification Services, who confirmed that NMT is operating to the required standards with no significant non-conformance. This opinion augurs well for the expansion of manufacturing capacity during the next two years. During 2000 and the first quarter of 2001, documents were correlated and application has been submitted to the US Food and Drug Administration (FDA) to register our syringe product range for additional intravenous (IV) usage. This will broaden the clinical application of the device and will be particularly valuable in supplying product for needle exchange programmes for drug abusers. To maintain quality, our suppliers undergo a thorough audit from NMT qualified staff. This programme is continuous, with all suppliers being re-audited over a two-year period. NMT has maintained a policy of protecting its intellectual property in key markets. The needle retraction mechanism patent has now been granted in most jurisdictions. Additional patent applications for butterfly, phlebotomy and catheter devices were filed during 1999 and 2000. To extend the life of the current syringe design, further patents will be sought. Patents supporting second-generation syringe design have already been filed with further additions planned during 2001. NMT has made favourable progress with regard to the patent infringement lawsuit brought by Medsafe Technologies LLC and Syringe Development Partners LLC ('SDP'). On 9 February 2001, the Federal Court in Indiana granted Summary Judgment in favour of NMT in respect of alleged infringement of the first of two patents. The Court left open for trial the matter of invalidity with regard to the first patent. During NMT's fund raising in June 2000 a second US patent, which is a continuation of the first patent, was issued to SDP. NMT has filed suit in Indiana for declaratory judgment relative to this second patent on the grounds of invalidity, non-infringement and unenforceability. SDP has filed suit against NMT for patent infringement. The same court in Indiana, which delivered summary judgment on the first SDP patent, will now hear the infringement and declaratory judgment actions relating to the second patent. NMT believes the Court's decision that there was no infringement of the first patent supports the Company's view that the NMT safety syringe does not infringe any of SDP's patents. We continue to believe that the outstanding claims can be successfully defended and that this lawsuit is unlikely to have a material impact on our business. Legislation Legislative pressure in the United States for the adoption of safety needle devices intensified last year. President Clinton signed the Needlestick Safety and Prevention Act on 6 November 2000, which was legislation requiring the revision of the Federal Occupational Safety and Health Administration (OSHA) blood-borne pathogens standard within six months. On 8 January 2001, OSHA revised the standard, confirming the requirement for employers to select safe needle devices, as they become available with employees being involved in the choice of safe needle device systems. OSHA also stated that these rules should become effective by 18 April 2001. While this is a relatively dynamic environment and further changes to the timetable may be published, it remains likely that safe needle technology will be mandated in the US during the summer of this year. This is excellent news for NMT. We believe that automatic needle retraction technology offers the ultimate solution to employee safety. NMT believes that governments in Europe will follow the American example in due course. There is already evidence in the UK, France and Italy of increasing awareness of the dangers associated with needlestick injury. NMT representatives have attended a number of informative medical conferences during the year where needlestick injury was a major item on the agenda. We believe that it is only a matter of time before Europe follows American practice. Sales and marketing Last year was also a watershed for sales and marketing. Graham Walker was appointed International Sales Director, with prime responsibility for sales development within Europe. For the nineteen years immediately preceding his appointment to NMT, Graham held senior management positions in Becton Dickinson, the leading syringe company. Steve Czick was appointed as President of New Medical Technology Inc in January 2001. He has had over 25 years experience in Johnson & Johnson, the majority of that time as Vice President of Sales and Marketing. These two appointments are crucial to the future success of NMT as the Group aims for impressive sales growth and market penetration during 2001 and beyond. Marketing and distribution strategy NMT has assessed other safety products that are currently available or being developed. We still believe that the NMT syringe is the best in class and will command a premium price. NMT's target markets are acute hospitals (infection control clinics, emergency rooms etc), correctional facilities (prisons), occupational health and vaccine programmes. The Company is also targeting pharmaceutical companies, which may wish to provide the NMT safety syringe as part of an added-value product with an associated drug, particularly for the treatment of HIV (Aids), HBV and HCV (Hepatitis B and C). Direct sales to end users via speciality distributors are considered the optimum route to market. Specialty distributors understand the value proposition and their sales organisations are technique sensitive. They often have a strong relationship with the end user and our product range will be targeted as a top priority brand within their sales portfolios. We have already secured agreements with a number of specialty distributors in the US and Continental Europe to ensure that we obtain the maximum market penetration for our product offering. We shall be seeking to secure further such agreements during 2001. Sales strategy During the year, the majority of NMT's sales came from the US. Our distributors remained enthusiastic despite frustrations with NMT's inability to satisfy demand and its limited range of products. Our US sales support team should be congratulated for their careful management throughout this difficult period. The willingness of our distributors to continue their partnership with NMT also confirms our belief that the opportunity for strong growth in the US exists and that the NMT product proposition remains the best available. Key factors augur well for NMT's future sales growth. We were awarded the Premier Purchasing Partners, LLP ('Premier') contract to supply its hospitals with NMT safety syringes. Premier is the largest group purchasing organization ('GPO') in the US. While NMT is not the sole supplier in this contract, it clearly validates our technology and the Group now has the opportunity to fight for market share. In November and December 2000, NMT supplied safety syringes to the Visiting Nurse Association of America to complete their respective influenza vaccination programmes in the states of Minnesota and California. This intensive trial of the NMT Safety Syringe, over a very short period of time, was further endorsement of our technology. Customer feedback was particularly valuable and we have made further enhancements to optimise our product performance. Towards the end of the summer, the NMT safety syringe was selected for a global clinical trial by a leading pharmaceutical company for use in the treatment of a major blood borne pathogenic disease. In early January 2001, the Group announced the relocation of our US office from Indiana to Massachusetts. Many medical device companies are situated in this State and we will be able to attract staff of high quality. NMT has made important additions to the sales executive team, principally in the US, but also in setting up a small sales team for the UK domestic market. The UK sales group will work with chosen distributors to ensure that the NMT product range receives adequate priority and selling time. NMT has also increased its clinical nurse support team to ensure that users of its product are adequately trained. We now have a strong sales and marketing team that is well qualified to deliver future growth. We believe that the demand for safety products will outstrip supply for the foreseeable future. Therefore, it is vital that our sales and marketing organisation establishes a firm market position as soon as possible, so that NMT products are those that the medical profession prefers to use, particularly in high-risk environments. Outlook The year 2001 is clearly critical. The transformation from product concept to high volume manufacture, accompanied by rapid sales growth, is a significant challenge. We have made substantial progress to date, although this has yet to show in our financial performance. The manufacturing challenge continues to remain difficult and time consuming, but focusing on a 'Process, Product and People' framework is resulting in major improvements. The management team is first-class and I have every confidence that NMT will make progress during 2001. Our competitors face many barriers to entry, which should not be underestimated. The safety syringe business is not only highly capital intensive, but also the complexity of distribution and manufacture demands a tremendous amount of time, energy, application and patience. The introduction of new legislation in the United States has created a huge opportunity for NMT and coupled with increasing awareness of safety issues in Europe, the Group will be able to build on this and other related developments to secure strong growth during future years. Roy Smith Chief Executive FINANCIAL REVIEW Operating Results Turnover of £441,000 primarily comprised of sales to the US and was significantly higher than the 1999 figure of £66,000, reflecting the expansion of 3cc syringe production output. Operating losses rose to £13.7m (1999: £7.4m loss) as the asset base of the business has grown, but include exceptional administration expenses of £3.0m, which comprise a £1.7m charge resulting from the impairment of intellectual property rights and £1.3m relating to restructuring costs and write off of certain deferred charges. Net interest receivable of £0.5m resulted in a loss after tax of £13.2m (1999: £7.1m). The loss per share of 8.8 pence reduced from 12.6 pence per share in 1999, as a result of an increase in the weighted average number of shares to 150.1m shares from 55.8m. This reflected the issue of 171.3m additional shares in the year. Financial position and cash flow The Group's financial position at year end may be summarised as follows: 2000 1999 £'000 £'000 Cash at bank and in hand 19,930 8,868 Bank loans - (1,500) Obligations under finance leases (2,205) (1,090) _____ _____ 17,725 6,278 _____ _____ The increase in net funds of £11.4m to £17.7m during the year resulted from the proceeds of share issues of £24.7m (net of expenses) during the year. The bank loan of £1.5m was repaid and additional leasing of £1.5m was secured on the Sortimat 2 assembly machine. A net cash outflow of £0.9m compared with a net inflow of £1.2m in 1999. After adjusting for movement in liquid resources and changes in net debt, a net funds inflow of £11.5m in 2000 compared with £4.5m in 1999. Net cash outflow from operating activities of £9.6m (1999: £7.1m outflow) comprised £10.4m cash outflow arising from operating performance, offset by a £0.8m reduction in working capital. Capital expenditure of £2.5m (1999: £2.6m) continued to reflect the build-up in manufacturing capacity with the purchase of automated assembly equipment and associated component tooling. Consolidated Profit and Loss Account For the year ended 31 December 2000 Restated 2000 1999 £'000 £'000 Turnover 441 66 Cost of sales (5,070) (2,799) _____ _____ Gross (loss) / profit (4,629) (2,733) Distribution costs (2,339) - _____ _____ Normal administration expenses (3,708) (5,297) Exceptional administration expenses (3,030) Total administration expenses (6,738) (5,297) Other operating income - 612 _____ _____ Operating loss (13,706) (7,418) Interest receivable 733 509 Interest payable (254) (150) _____ _____ Loss on ordinary activities before and after tax (13,227) (7,059) _____ _____ Loss per share Basic and diluted (8.8)p (12.6)p _____ _____ Balance Sheets At 31 December 2000 Group Company 2000 1999 2000 1999 £'000 £'000 £'000 Fixed assets Intangible assets - 1,810 - 1,110 Tangible assets 9,940 7,064 9,940 7,064 9,940 8,874 9,940 8,174 _____ _____ _____ _____ Current assets Stocks 960 520 935 520 Debtors 729 742 5,306 3,540 Cash at bank and in hand 19,930 8,868 19,867 8,849 21,619 10,130 26,108 12,909 _____ _____ _____ ______ Creditors Amounts falling due (3,328) (2,555) (3,173) (2,514) within one year _____ _____ _____ _____ Net current assets 18,291 7,575 22,935 10,395 _____ _____ _____ _____ Total assets less current liabilities 28,231 16,449 32,875 18,569 ______ _____ _____ _____ Creditors Amounts falling due (1,661) (1,782) (1,661) (1,782) after more than one year _____ _____ _____ _____ Net assets 26,570 14,667 31,214 16,787 _____ _____ _____ _____ Capital and reserves Called up share capital 11,708 3,142 11,708 3,142 Share premium account 39,949 23,784 39,949 23,784 Profit and loss account (25,087) (12,259) (20,443) (10,139) _____ _____ _____ _____ Equity shareholders' funds 26,570 14,667 31,214 16,787 _____ _____ _____ _____ Statement of Total Recognised Gains and Losses For the year ended 31 December 2000 Group Company 2000 1999 2000 1999 £'000 £'000 £000 £'000 Loss on ordinary activities after tax (13,227) (7,059)(10,744) (5,389) Exchange adjustment on retranslation of (41) - - - subsidiary _____ _____ _____ _____ Total gains and losses relating to the year (13,268) (7,059)(10,744) (5,389) _____ _____ _____ _____ Reconciliation of Shareholders' Funds For the year ended 31 December 2000 Group Company 2000 1999 2000 1999 £'000 £'000 £000 £'000 Total gains and losses relating to the year (13,268) (7,059) (10,744) (5,389) Placing and Open Offer 24,117 15,346 24,117 15,346 Share options - exercised 614 614 - application of UITF 17 440 55 440 55 _____ _____ _____ _____ Total movements during the year 11,903 8,342 14,427 10,012 Shareholders' funds at 1 January 14,667 6,325 16,787 6,775 _____ _____ ______ _____ Shareholders' funds at 31 December 26,570 14,667 31,214 16,787 _____ _____ _____ _____ Consolidated Cash Flow Statement For the year ended 31 December 2000 2000 1999 £'000 £'000 Net cash outflow from operating activities (9,632) (7,140) _____ _____ Returns on investments and servicing of finance Interest received 697 472 Interest paid (254) (150) 443 322 _____ _____ Capital expenditure and financial investment Purchase of tangible fixed assets (2,523) (2,575) Cash outflow before management of liquid resources and (11,712) (9,393) financing _____ _____ Management of liquid resources Cash (placed on) term deposit (11,934) (4,300) _____ _____ Financing Term loan (repayment) (1,500) - Finance lease - repayment of principal (457) (496) Proceeds on issue of shares 26,079 16,025 Expenses of share issue (1,348) (679) 22,774 14,850 _____ _____ (Decrease)/Increase in cash in the year (872) 1,157 _____ _____
UK 100

Latest directors dealings